<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
82711-101-02
</NDCCode>
<PackageDescription>
1 BOTTLE in 1 BOX (82711-101-02) / 20 mg in 1 BOTTLE (82711-101-01)
</PackageDescription>
<NDC11Code>
82711-0101-02
</NDC11Code>
<ProductNDC>
82711-101
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Kids Oral Care Strawberry Flavor
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Xylitol, Calcium Lactate
</NonProprietaryName>
<DosageFormName>
SPRAY
</DosageFormName>
<RouteName>
DENTAL
</RouteName>
<StartMarketingDate>
20250313
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
UNAPPROVED DRUG OTHER
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
TOOTHFILM INC.
</LabelerName>
<SubstanceName>
CALCIUM LACTATE; XYLITOL
</SubstanceName>
<StrengthNumber>
.02; 2
</StrengthNumber>
<StrengthUnit>
mg/20mg; mg/20mg
</StrengthUnit>
<Pharm_Classes>
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-03-24
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250313
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>